Exercise Capacity Respiratory Muscle Strength Dyspnea and Physical Activity in Pediatric Pulmonary Arterial Hypertension

NCT05124015 | Completed

• 1 other identifier: Gazi University 128
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study was to evaluate exercise capacity, respiratory muscle strength, pulmonary function, dyspnea and physical activity levels in pediatric PAH patients and compare them with healthy controls. The secondary aim of the study was; To investigate the relationship of dyspnea with exercise capacity, respiratory muscle strength, respiratory functions, physical activity and blood count parameters in pediatric PAH patients.

Conditions

Pulmonary Arterial Hypertension

Keywords

muscle strength; exercise; exercise test; physical activity; pulmonary arterial hypertension; Respiratory Function Tests

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Functional exercise capacity was evaluated using the 6- Minute Walk Test. 6- Minute Walk Test will be applied according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  First Day

Secondary Outcomes (14)

• Respiratory muscle strength

  First Day

• Pulmonary function (Forced vital capacity (FVC))

  First Day

• Pulmonary function (Forced expiratory volume in the first second (FEV1))

  First day

• Pulmonary function (FEV1 / FVC)

  First day

• Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

  First Day

Study Arms (2)

Patients with pulmonary arterial hypertension

Exercise capacity using six minute walk test, respiratory muscle strength using mouth pressure device, pulmonary function using spirometry, dyspnea using Modified Borg scale physical activity using multi-sensor activity monitor.

Healthy controls

Exercise capacity using six minute walk test, respiratory muscle strength using mouth pressure device, pulmonary function using spirometry, dyspnea using Modified Borg scale physical activity using multi-sensor activity monitor.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

13 patients with PAH and 15 healthy individuals were included in the study.

You may qualify if:

• Between the ages of 6-18
• Diagnosed with pulmonary arterial hypertension
• Clinically stable and receiving standard medical treatment
• \) To be between the ages of 6-18

You may not qualify if:

• \) Having any acute infection, orthopedic, neurological, cooperation, vision or hearing problems that may interfere during the measurements
• Having any acute or chronic illness
• Active or ex-smoker

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Ankara, Çankaya, 06580, Turkey (Türkiye)

Location

Related Publications (5)

• Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.

  PMID: 26320113 BACKGROUND

• McGoon M, Gutterman D, Steen V, Barst R, McCrory DC, Fortin TA, Loyd JE; American College of Chest Physicians. Screening, early detection, and diagnosis of pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines. Chest. 2004 Jul;126(1 Suppl):14S-34S. doi: 10.1378/chest.126.1_suppl.14S.

  PMID: 15249493 BACKGROUND

• Douwes JM, Hegeman AK, van der Krieke MB, Roofthooft MT, Hillege HL, Berger RM. Six-minute walking distance and decrease in oxygen saturation during the six-minute walk test in pediatric pulmonary arterial hypertension. Int J Cardiol. 2016 Jan 1;202:34-9. doi: 10.1016/j.ijcard.2015.08.155. Epub 2015 Aug 28.

  PMID: 26386916 BACKGROUND

• Cappelleri JC, Hwang LJ, Mardekian J, Mychaskiw MA. Assessment of measurement properties of peak VO(2) in children with pulmonary arterial hypertension. BMC Pulm Med. 2012 Sep 10;12:54. doi: 10.1186/1471-2466-12-54.

  PMID: 22963001 BACKGROUND

• Smith G, Reyes JT, Russell JL, Humpl T. Safety of maximal cardiopulmonary exercise testing in pediatric patients with pulmonary hypertension. Chest. 2009 May;135(5):1209-1214. doi: 10.1378/chest.08-1658. Epub 2008 Dec 31.

  PMID: 19118264 BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Ece Baytok, Pt. MSc

  Gazi University, Faculty of Health Sciences, Department of Cardiopulmonary Physical Therapy and Rehabilitation

  STUDY CHAIR

• Gülşah Barğı, PhD. Pt.

  Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Betül Yoleri, Pt. MSc

  Gazi University, Faculty of Health Sciences, Department of Cardiopulmonary Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Fatma İncedere, Dr

  Gazi University

  PRINCIPAL INVESTIGATOR

• Serdar Kula, Prof.Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Fatma Sedef Tunaoğlu, Prof.Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral Boşnak Güçlü, Prof. Dr.

  Gazi University, Faculty of Health Sciences, Department of Cardiopulmonary Physical Therapy and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 17, 2021
• Study Start: November 10, 2019
• Primary Completion: April 10, 2021
• Study Completion: January 1, 2022
• Last Updated: March 25, 2025

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)